The voluntary recall includes the company’s Irbesartan tablets and Hydrochlorothiazide tablets at the consumer level.
In an Oct. 14 release, the agency said it made the assessment based on results from laboratory testing.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the FDA wrote. “Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US.”
Lupin Pharmaceuticals, Inc. issues voluntarily nationwide recall of all Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets due to potential presence of N-nitrosoirbesartan impurity (FDA)
The administration noted that Lupin Pharmaceuticals had discontinued the marketing of Irbesartan and Irbesartan and HCTZ tabs in January.
From October 2018 to Sept. 30, 2021, Lupin Pharmaceuticals reportedly received four reports of illness from Irbesartan and zero reports from Irbesartan and Hydrochlorothiazide.
The Irbesartan tablets USP 75mg, 150mg and 300mg are packaged in 30- and 90-count bottles and were distributed to wholesalers, drug chains, mail-order pharmacies and supermarkets nationwide.
“Irbesartan Tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine and proteinuria,” the FDA explained.
Irbesartan and Hydrochlorothiazide tablet USP, 150mg/12.5mg and 300mg/12.5mg were also packaged in 30- and 90-count bottles and distributed to wholesalers, drug chains, mail-order pharmacies and supermarkets across the country.
According to the FDA, Lupin Pharmaceuticals is notifying its wholesalers, distributors, drug chains, mail-order pharmacies and supermarkets both over the phone and through recall notification, in addition to arranging for the return of all the recalled product lots.
The recall notice advised that patients taking Irbesartan tablets USP, 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide tablets USP, 150mg/12.5mg and 300mg/12.5mg should continue to do so and contact their pharmacist, physician or medical provider for information regarding alternative treatment.
Consumers, wholesalers, distributors or retailers with questions about the recall should contact Inmar Rx Solutions Inc. at (855) 769-3988 / (855) 769-3989 and recalled lots should be returned to Inmar Rx Solutions Inc. for reimbursement.
The lot number can be found on the side of the bottle label.